Understanding the Scope and Claims of United States Patent 11,083,724: A Detailed Analysis
Introduction
United States Patent 11,083,724, titled "Rimegepant for CGRP related disorders," is a significant patent in the pharmaceutical industry, particularly in the treatment of migraine and other calcitonin gene-related peptide (CGRP) related disorders. This patent, assigned to Biohaven Pharmaceutical Ireland DAC, has far-reaching implications for both the treatment of migraines and the pharmaceutical landscape.
Patent Overview
Issuance and Assignment
The patent was issued on August 10, 2021, and is assigned to Biohaven Pharmaceutical Ireland DAC, with inventors Vladimir Coric and Robert Croop[1][5].
Patent Title and Abstract
The patent is titled "Rimegepant for CGRP related disorders" and discloses methods of treating CGRP-related disorders, such as migraine, by administering rimegepant or a pharmaceutically acceptable salt thereof. It also covers pharmaceutical compositions comprising rimegepant and kits that include these compositions along with instructions[1][5].
Claims and Scope
Claim Types
The patent includes various claim types, such as use claims, composition claims, and dosage form claims. These claims are crucial in defining the scope of protection for the invention.
- Use Claims: These claims cover the methods of treating CGRP-related disorders, including migraine, using rimegepant.
- Composition Claims: These claims pertain to the pharmaceutical compositions that contain rimegepant.
- Dosage Form Claims: These claims specify the dosage forms, such as orally disintegrating tablets, which are part of the patented invention[1][2].
Claim Language and Scope
The claim language is detailed and specific, ensuring that the patent scope is well-defined. For example, claim 1 of the '724 patent specifies a pharmaceutical composition comprising a pharmaceutically acceptable carrier and rimegepant, highlighting the precise formulation and application of the drug[2].
Patent Landscape
Global Protection
The patent has fifteen patent family members in thirteen countries, including Australia, Brazil, Canada, China, and several European countries. This global protection ensures that the invention is safeguarded across multiple jurisdictions[1].
Expiration Dates
The patent is set to expire on March 25, 2039, which is a critical date for both the patent holder and potential generic manufacturers. This expiration date marks the end of the exclusive period during which Biohaven Pharmaceutical Ireland DAC can market rimegepant without generic competition[5].
Litigation and Enforcement
Current Litigation
Pfizer Inc. and Pfizer Ireland Pharmaceuticals are currently involved in litigation against Aurobindo Pharma regarding the submission of an Abbreviated New Drug Application (ANDA) for a generic version of NURTEC ODT (rimegepant sulfate). The lawsuit seeks to prevent the approval of the generic version before the patent's expiration, alleging infringement under 35 U.S.C. § 271(e)(2)(A)[2].
Patent Infringement Claims
The lawsuit includes claims that Aurobindo’s ANDA product will directly infringe, induce, and/or contribute to the infringement of the '724 patent. Pfizer is seeking a judgment declaring the infringement and an order to preliminarily and permanently enjoin Aurobindo from manufacturing, using, offering for sale, selling, and/or importing the generic product into the United States[2].
Pharmaceutical Product Details
NURTEC ODT
NURTEC ODT, the trade name for rimegepant sulfate, is an orally disintegrating tablet approved for the acute treatment of migraine with or without aura in adults and the preventive treatment of episodic migraine in adults. This product is protected under the '724 patent and is a key asset for Pfizer and Biohaven Pharmaceutical Ireland DAC[1][2].
Impact on the Pharmaceutical Industry
Innovation and Competition
The '724 patent highlights the ongoing debate about patent quality and scope. Patents like this one can influence innovation by providing exclusive rights to the patent holder, which can both incentivize and hinder innovation depending on how they are used. The litigation surrounding this patent underscores the complexities and costs associated with patent enforcement and the potential barriers to generic competition[3].
Generic Availability
The expiration of the '724 patent in 2039 will open the door for generic versions of rimegepant, potentially increasing competition and reducing costs for patients. However, until then, the patent holder will continue to enjoy exclusive marketing rights, which can impact the availability and pricing of the drug[5].
Expert Insights and Statistics
Industry Expert Views
Industry experts often highlight the importance of patent scope and clarity in ensuring that patents do not overly broaden or obscure the invention, which can lead to increased litigation costs and decreased innovation. For instance, the Federal Trade Commission has noted concerns about the breadth and clarity of software and internet patents, which can impede innovation[3].
Market Impact
The market impact of the '724 patent is significant, given the prevalence of migraines and the need for effective treatments. Rimegepant has been shown to be effective in treating migraines, and the patent protection ensures that the drug remains a valuable asset for its developers and marketers.
Key Takeaways
- Patent Scope: The '724 patent covers methods of treating CGRP-related disorders using rimegepant, including specific pharmaceutical compositions and dosage forms.
- Global Protection: The patent has extensive global protection across thirteen countries.
- Litigation: Ongoing litigation aims to prevent generic competition before the patent's expiration in 2039.
- Pharmaceutical Product: NURTEC ODT is the trade name for rimegepant sulfate, approved for acute and preventive treatment of migraines.
- Industry Impact: The patent influences innovation, competition, and the availability of generic versions of the drug.
FAQs
What is the main subject of United States Patent 11,083,724?
The main subject of United States Patent 11,083,724 is the use of rimegepant for treating CGRP-related disorders, such as migraine.
Who are the inventors of the '724 patent?
The inventors of the '724 patent are Vladimir Coric and Robert Croop.
What is the expiration date of the '724 patent?
The '724 patent is set to expire on March 25, 2039.
What product is protected under the '724 patent?
The product protected under the '724 patent is NURTEC ODT (rimegepant sulfate), an orally disintegrating tablet.
Why is there ongoing litigation related to the '724 patent?
The ongoing litigation is due to Aurobindo Pharma's submission of an ANDA for a generic version of NURTEC ODT, which Pfizer alleges will infringe the '724 patent before its expiration.
Sources
- DrugPatentWatch, "Patent 11,083,724 - Rimegepant for CGRP related disorders"
- RPX Insight, "In the United States District Court - Pfizer Inc. v. Aurobindo Pharma"
- Hoover Institution, "Patent Claims and Patent Scope"
- CAFC, "Eli Lilly and Company v. Teva Pharmaceuticals"
- Drugs.com, "Generic Nurtec ODT Availability"
